[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Proposed Rules]
[Pages 42290-42295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14901]



[[Page 42289]]

Vol. 85

Monday,

No. 134

July 13, 2020

Part V





Department of Justice





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Drug Enforcement Administration





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21 CFR Part 1308





Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 
4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in Schedule I; 
Proposed Rule and Temporary Rule

  Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / 
Proposed Rules  

[[Page 42290]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-479]


Schedules of Controlled Substances: Placement of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in Schedule 
I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes placing 
naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (trivial 
names: NM2201; CBL2201), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide (trivial name: 5F-AB-PINACA), 
1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide 
(trivial names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL 
BINACA; CUMYL-4CN-BINACA, SGT-78), methyl 2-(1-(cyclohexylmethyl)-1H-
indole-3-carboxamido)-3-methylbutanoate (trivial names: MMB-CHMICA, 
AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-
pyrrolo[2,3-b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA), 
including their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, in 
schedule I of the Controlled Substances Act. If finalized, this action 
would make permanent the existing regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule I 
controlled substances on persons who handle (manufacture, distribute, 
import, export, engage in research, conduct instructional activities or 
chemical analysis with, or possess) or propose to handle NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA.

DATES: Comments must be submitted electronically or postmarked on or 
before August 12, 2020.
    Interested persons may file written comments on this proposal in 
accordance with 21 CFR 1308.43(g). Commenters should be aware that the 
electronic Federal Docket Management System will not accept comments 
after 11:59 p.m. Eastern Time on the last day of the comment period.
    Interested persons may file a request for hearing or waiver of 
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 
1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers 
of an opportunity for a hearing or to participate in a hearing must be 
received on or before August 12, 2020.

ADDRESSES: Interested persons may file written comments on this 
proposal in accordance with 21 CFR 1308.43(g). Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period. To ensure proper handling of comments, please reference 
``Docket No. DEA-479'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
(DEA) encourages that all comments be submitted electronically through 
the Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission you will receive a Comment 
Tracking Number for your comment. Please be aware that submitted 
comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary. Should you wish to mail a 
paper comment, in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attn: DEA 
Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.
     Hearing requests: All requests for a hearing and waivers 
of participation must be sent to: Drug Enforcement Administration, 
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 
22152. All requests for hearing and waivers of participation should 
also be sent to: (1) Drug Enforcement Administration, Attn: Hearing 
Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) 
Drug Enforcement Administration, Attn: DEA Federal Register 
Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 
22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to http://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at http://www.regulations.gov for easy 
reference.

Request for Hearing or Waiver of Participation in a Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the

[[Page 42291]]

record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. Such requests or notices must conform to the requirements of 
21 CFR 1308.44(a) or (b), as applicable, and include a statement of the 
person's interests in the proceeding and the objections or issues, if 
any, concerning which the person desires to be heard. Any waiver must 
conform to the requirements of 21 CFR 1308.44(c) and may include a 
written statement regarding the interested person's position on the 
matters of fact and law involved in any hearing.
    All requests for hearing and waivers of participation must be sent 
to DEA using the address information provided above.

Legal Authority

    The Controlled Substances Act (CSA) provides that proceedings for 
the issuance, amendment, or repeal of the scheduling of any drug or 
other substance may be initiated by the Attorney General (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS); \1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This proposed action is supported by a 
recommendation from the Assistant Secretary for Health of HHS 
(Assistant Secretary) and an evaluation of all other relevant data by 
DEA. If finalized, this action would make permanent the existing 
temporary regulatory controls and administrative, civil, and criminal 
sanctions of schedule I controlled substances on any person who handles 
or proposes to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in 
carrying out the Secretary's scheduling responsibilities under the 
CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of HHS has delegated to the Assistant Secretary for Health 
of HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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Background

    On July 10, 2018, DEA published an order in the Federal Register 
amending 21 CFR 1308.11(h) to temporarily place naphthalen-1-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (trivial names: NM2201; CBL2201), 
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide (trivial name: 5F-AB-PINACA), 1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial names: 4-CN-
CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-
BINACA, SGT-78), methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate (trivial names: MMB-CHMICA, AMB-CHMICA), 
and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA) in schedule I 
of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). 83 FR 31877. That temporary scheduling order was effective on 
the date of publication, and was based on findings by the former Acting 
Administrator of DEA (Acting Administrator) that the temporary 
scheduling of these five synthetic cannabinoids (SCs) was necessary to 
avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 
811(h)(1). Subsection 811(h)(2) requires that the temporary control of 
these substances expire two years from the effective date of the 
scheduling order, which for these five substances had an effective date 
of July 10, 2018. However, this same subsection also provides that 
during the pendency of proceedings under 21 U.S.C. 811(a)(1) with 
respect to a substance, the temporary scheduling of that substance may 
be extended for up to one year. Proceedings for the scheduling of a 
substance under 21 U.S.C. 811(a) may be initiated by the Attorney 
General (delegated to the Administrator of DEA pursuant to 28 CFR 
0.100) on his own motion, at the request of the Secretary of HHS,\2\ or 
on the petition of any interested party. An extension of the existing 
temporary order is being ordered by the Acting Administrator in a 
separate action, and is being simultaneously published elsewhere in 
this issue of the Federal Register.
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    \2\ Because the Secretary of HHS has delegated to the Assistant 
Secretary the authority to make domestic drug scheduling 
recommendations, for purposes of this proposed scheduling action, 
all subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
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    The Acting Administrator, on his own motion, is initiating 
proceedings under 21 U.S.C. 811(a)(1) to permanently schedule NM2201, 
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. DEA 
has gathered and reviewed the available information regarding the 
pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, 
and the relative potential for abuse for these five SCs. On February 4, 
2019, the Acting Administrator submitted a request to the Assistant 
Secretary to provide DEA with a scientific and medical evaluation of 
available information and a scheduling recommendation for NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, in 
accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the 
scientific and medical evidence, on May 29, 2020, the Assistant 
Secretary submitted HHS's scientific and medical evaluation and 
scheduling recommendation for these five substances to the Acting 
Administrator. Upon receipt of the scientific and medical evaluation 
and scheduling recommendation from HHS, DEA reviewed the documents and 
all other relevant data, and conducted its own eight-factor analysis of 
the abuse potential of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA, in accordance with 21 U.S.C. 811(c).

Proposed Determination to Schedule NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA

    As discussed in the background section, the Acting Administrator is 
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add NM2201, 
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA 
permanently to schedule I of the CSA. DEA has reviewed the scientific 
and medical evaluation and scheduling recommendation received from HHS, 
and all other relevant data, and conducted its own eight-factor 
analysis of the abuse potential of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, pursuant to 21 U.S.C. 
811(c). Included below is a brief summary of each factor as analyzed by 
HHS and DEA, and as considered by DEA in its proposed scheduling 
action. Please note that both DEA Eight-Factor and HHS Eight-Factor 
analyses and the Assistant Secretary's May 29, 2020, letter are 
available in their entirety under the tab ``Supporting Documents'' of 
the public docket of this action at http://www.regulations.gov, under 
Docket Number ``DEA-479.''
    1. The Drug's Actual or Relative Potential for Abuse: The term 
``abuse'' is not defined in the CSA. However, the legislative history 
of the CSA suggests that DEA consider the following criteria in 
determining whether a particular

[[Page 42292]]

drug or substance has a potential for abuse: \3\
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    \3\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970 
U.S.C.C.A.N. 4566, 4603.

    (a) There is evidence that individuals are taking the drug or 
drugs containing such a substance in amounts sufficient to create a 
hazard to their health or to the safety of other individuals or to 
the community; or
    (b) There is significant diversion of the drug or drugs 
containing such a substance from legitimate drug channels; or
    (c) Individuals are taking the drug or drugs containing such a 
substance on their own initiative rather than on the basis of 
medical advice from a practitioner licensed by law to administer 
such drugs in the course of his professional practice; or
    (d) The drug or drugs containing such a substance are new drugs 
so related in their action to a drug or drugs already listed as 
having a potential for abuse to make it likely that the drug will 
have the same potentiality for abuse as such drugs, thus making it 
reasonable to assume that there may be significant diversions from 
legitimate channels, significant use contrary to or without medical 
advice, or that it has a substantial capability of creating hazards 
to the health of the user or to the safety of the community.

    In its recommendation, HHS noted that abuse of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA has a 
substantial capability to create a hazard to the health of the 
individual users and the safety of others within the community. Adverse 
effects observed following the ingestion of NM2201, 5F-AB-PINACA, or 4-
CN-CUMYL-BUTINACA included diaphoresis, tachycardia, hypertension, 
seizures, agitation, violence, nausea, and memory impairment (see 
factor 6). SCs, including NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, 
MMB-CHMICA, and 5F-CUMYL-P7AICA, have been generally found to be easily 
accessible and difficult to detect in standard urine drug screens, 
which contributes to their popularity and high rates of abuse.
    As stated by HHS, there are no Food and Drug Administration (FDA)-
approved drug products containing NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA for treatment in the United 
States, and there appear to be no legitimate sources for these 
substances as marketed drugs. In addition, HHS stated that the human 
use of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA is assumed to be on an individual's own initiative, rather 
than on the basis of medical advice from a practitioner licensed by law 
to administer drugs, since these SCs are not approved for medical use 
and are not formulated or available for clinical use. As noted by HHS, 
individuals may be using these five SCs on their own initiative, 
possibly because they are seeking the same cannabinoid-like effects as 
other schedule I cannabinoids while avoiding the criminal penalties 
associated with those substances. Further, published scientific and 
medical literature and law enforcement reports indicate that 
individuals are taking these SCs on their own initiative, rather than 
on the basis of medical advice of a licensed practitioner.
    As stated by HHS, the pharmacological data for NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA show that 
these substances, similar to other schedule I SCs, bind to and activate 
the CB1 cannabinoid receptors. In drug discrimination studies either 
sponsored by the National Institute on Drug Abuse or conducted by FDA's 
National Center for Toxicological Research under an Interagency 
Agreement, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA, similar to other schedule I SCs (e.g., JWH-018, 
AM2201, ADB-PINACA, AB-FUBINACA), fully substitute for delta-9-
tetrahydrocannabinol (THC) in animals trained to discriminate THC from 
vehicle control. Documented adverse effects associated with NM2201, 5F-
AB-PINACA, and 4-CN-CUMYL-BUTINACA in the United States and abroad, and 
5F-CUMYL-P7AICA in Europe, similar to other schedule I SCs, include 
tachycardia, aggressive or violent behavior, confusion, depressed 
mental status, severe agitation, psychosis, and/or death in some 
instances (see factors 4 and 6). HHS stated that because of the 
psychological and cognitive disturbances associated with such 
responses, it is reasonable to assume that these five SCs have a 
substantial capability to be a hazard to the health of the user and to 
the safety of the community.
    The above information collectively indicates that the relative 
potential for abuse of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA is similar to other schedule I CB1 receptor 
agonists.
    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: Within its recommendation, HHS described in vitro receptor 
binding and functional assays that were conducted with NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. These 
results indicate that NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA, similar to other schedule I SCs, bind to 
CB1 receptors and act as full cannabinoid agonists at CB1 receptors. 
Drug discrimination studies were conducted in animals to evaluate 
whether the five SCs have cannabinoid characteristics similar to 
substances in schedule I of the CSA. Each of the five SCs were shown to 
fully substitute for the discriminative stimulus effects produced by 
THC, a schedule I substance.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance:
    NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA are all potent cannabinoid agonists that are 
pharmacologically similar to THC and several schedule I SCs.
    As stated by HHS, when FDA approves a drug under the Federal Food,
    Drug, and Cosmetic Act for human or animal medical use, such drug 
is considered to have a currently accepted medical use in the United 
States. In the absence of such approval by FDA, a drug may be 
considered to have a currently accepted medical use in the United 
States if DEA concludes that the drug satisfies all of the following 
five elements: \4\
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    \4\ 57 FR 10492 (1992), pet. for rev. denied, Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).

    a. The drug's chemistry is known and reproducible;
    b. There are adequate safety studies;
    c. There are adequate and well-controlled studies proving 
efficacy;
    d. The drug is accepted by qualified experts; and
    e. The scientific evidence is widely available.

    According to HHS, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA have not been approved by FDA as a human or 
animal drug product in the United States or, to FDA's knowledge, been 
approved for medical use in any other country. Moreover, there are no 
well-controlled clinical studies showing safety or efficacy for any of 
these cannabinoids. In addition, there is no evidence by qualified 
experts that the five cannabinoids are accepted as having therapeutic 
uses. Therefore, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA have no

[[Page 42293]]

currently accepted medical use for treatment in the United States.
    4. Its History and Current Pattern of Abuse: NM2201 was first 
identified in the United States in November 2012 in seized drug 
evidence, followed by 5F-AB-PINCA (August 2013), MMB-CHMICA (December 
2015), 4-CN-CUMYL BUTINACA (January 2016), and most recently 5F-CUMYL-
P7AICA (February 2018). The European Monitoring Centre for Drugs and 
Drug Addiction reported a seizure of 50 kg of 4-CN-CUMYL-BUTINACA in 
Europe in 2016. According to the National Forensic Laboratory 
Information System \5\ (NFLIS), although the first encounter of 4-CN-
CUMYL-BUTINACA in the United States occurred in January 2016, the 
increase in encounters did not occur until later in 2017. Similarly, 
prior to the first encounter of 5F-CUMYL-P7AICA in the United States in 
February 2018, two deaths related to the use of this substance had 
already been documented in Europe in November and December 2016 (see 
factor 6). The data also show that SCs originate in China and these 
substances are often abused in Europe and other countries before being 
trafficked in the United States.
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    \5\ NFLIS is a DEA program and a national forensic laboratory 
reporting system that systematically collects results from drug 
chemistry analyses conducted by state and local forensic 
laboratories in the United States. The NFLIS database also contains 
Federal data from U.S. Customs and Border Protection (CBP). NFLIS 
only includes drug chemistry results from completed analyses.
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    HHS stated that compared to cannabis, acute fatal poisoning appears 
to be more prevalent with SCs. As demonstrated by NFLIS, law 
enforcement encounters of these five SCs have decreased following their 
placement in schedule I (see Factor 5).
    5. The Scope, Duration, and Significance of Abuse: Following 
multiple scheduling actions controlling SCs, law enforcement and health 
care professionals have encountered novel SCs, including NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, that 
differ from previously scheduled SCs and one another only by small 
structural modifications intended to avoid prosecution while 
maintaining the pharmacological effects. NFLIS detailed 5,259 reports 
from forensic laboratories for these five substances as follows: 2,938 
reports of NM2201, 1,200 reports of 5F-AB-PINACA, 797 reports of 4-CN-
CUMYL-BUTINACA, 323 reports of MMB-CHMICA, and 1 report of 5F-CUMYL-
P7AICA for a period from November 2012 through June 2020.\6\ Reports 
peaked for NM2201 and 5F-AB-PINACA in 2015, for MMB-CHMICA in 2017, and 
for 4-CN-CUMYL-BUTINACA in 2018. The report of 5F-CUMYL-P7AICA also 
occurred in 2018. In addition, the System to Retrieve Drug Evidence 
(STRIDE) \7\ and STARLiMS \8\ have 644 reports involving NM2201 (311 
reports), 5F-AB-PINACA (202 reports), 4-CN-CUMYL-BUTINACA (13 reports), 
and MMB-CHMICA (118 reports) from 2013 through June 2020. A full 
presentation of the NFLIS and STRIDE/STARLiMS reports by substance and 
by year are available in the Supporting Documents of the public docket 
available at http://www.regulations.gov.
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    \6\ Query date June 3, 2020.
    \7\ STRIDE is a database of drug exhibits sent to DEA 
laboratories for analysis. Exhibits from the database are from DEA, 
other federal agencies, and some local law enforcement agencies.
    \8\ STARLiMS is a laboratory information management system that 
systematically collects results from drug chemistry analyses 
conducted by DEA laboratories. On October 1, 2014, STARLiMS replaced 
STRIDE as DEA's laboratory drug evidence data system of record.
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    6. What, if Any, Risk There is to the Public Health: HHS and DEA 
documented multiple cases where NM2201, 5F-AB-PINACA, and 4-CN-CUMYL-
BUTINACA have been identified in overdoses and/or cases involving death 
attributed to their abuse in the United States and abroad. In addition, 
HHS and DEA reported exposure to 5F-CUMYL-P7AICA resulted in two deaths 
in November and December 2016 in Europe. Adverse health effects 
reported from these incidents involving NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, and 5F-CUMYL-P7AICA included diaphoresis, tachycardia, 
hypertension, seizures, agitation, violence, nausea, and memory 
impairment, and/or death. By sharing pharmacological similarities with 
schedule I substances (THC, JWH-018, and other temporarily and 
permanently controlled schedule I SCs), NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA are SCs with no 
approved medical use that pose serious risk to the abuser. While no 
adverse event information is currently available for MMB-CHMICA, 
substantial law enforcement seizures and the pharmacological similarity 
of MMB-CHMICA to other currently controlled schedule I SCs with known 
risks to public health (i.e., AB-CHMINACA, AB-FUBINACA, JWH-018) 
demonstrate an imminent hazard to public safety (see factor 5).
    7. Its Psychic or Physiological Dependence Liability: As stated by 
HHS, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA have pharmacological profiles that are similar to other 
schedule I SCs. There are no clinical studies evaluating dependence 
liabilities specific to NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA. HHS noted that while the five SCs are 
pharmacologically related to several current schedule I SCs such as 
JWH-018, XLR11, and AKB-48, there are still no specific studies 
examining their respective psychic or dependence liability. HHS stated 
that it is reasonable to assume, given the pharmacology of the five 
SCs, the likelihood of such a withdrawal effect being associated with 
the use of these cannabinoids as well.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: As noted by HHS, NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA are not 
immediate precursors of any controlled substance of the CSA as defined 
by 21 U.S.C. 802(23).
    Conclusion: After considering the scientific and medical evaluation 
conducted by HHS, HHS's recommendation, and DEA's own eight-factor 
analysis, DEA finds that the facts and all relevant data constitute 
substantial evidence of the potential for abuse of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. As such, 
DEA hereby proposes to permanently schedule NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA as controlled 
substances under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendation of the Assistant Secretary for Health of HHS and review 
of all other available data, the Acting Administrator of DEA, pursuant 
to 21 U.S.C. 811(a) and 812(b)(1), finds that:
    1. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA have a high potential for abuse that is comparable to 
other schedule I substances such as THC and JWH-018;
    2. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA have no

[[Page 42294]]

currently accepted medical use in treatment in the United States; and
    3. There is a lack of accepted safety for use of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA under 
medical supervision.
    Based on these findings, the Acting Administrator of DEA concludes 
that naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 
(trivial names: NM2201; CBL2201); N-(1-amino-3-methyl-1-oxobutan-2-yl)-
1-(5-fluoropentyl)-1H-indazole-3-carboxamide (trivial name: 5F-AB-
PINACA); 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-
carboxamide (trivial names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-
BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA, SGT-78); methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate (trivial 
names: MMB-CHMICA, AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2-
phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (trivial 
name: 5F-CUMYL-P7AICA), including their salts, isomers and salts of 
isomers, whenever the existence of such salts, isomers, and salts of 
isomers is possible, warrant control in schedule I of the CSA. 21 
U.S.C. 812(b)(1).

Requirements for Handling NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, 
MMB-CHMICA, and 5F-CUMYL-P7AICA

    If this rule is finalized as proposed, NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA would continue \9\ to 
be subject to the CSA's schedule I regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, including the following:
---------------------------------------------------------------------------

    \9\ NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA are currently subject to schedule I controls on a 
temporary basis, pursuant to 21 U.S.C. 811(h). 83 FR 31877, July 10, 
2018.
---------------------------------------------------------------------------

    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA, or who desires to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, is required to be registered 
with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 
957, and 958 and in accordance with 21 CFR parts 1301 and 1312.
    2. Security. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA are subject to schedule I security requirements and 
must be handled and stored pursuant to 21 U.S.C. 821, 823 and in 
accordance with 21 CFR 1301.71-1301.93. Non-practitioners handling 
these five substances must also comply with the employee screening 
requirements of 21 CFR 1301.90-1301.93.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA must be in compliance with 21 U.S.C. 825 and 
958(e), and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Any person registered with DEA to handle NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA must 
have an initial inventory of all stocks of controlled substances 
(including NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA) on hand on the date the registrant first engages in 
the handling of controlled substances pursuant to 21 U.S.C. 827 and 
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA) on 
hand every two years, pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records and Reports. Every DEA registrant is required to 
maintain records and submit reports with respect to NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA pursuant 
to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 
and 1312.
    7. Order Forms. Every DEA registrant who distributes NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA is 
required to comply with the order form requirements, pursuant to 21 
U.S.C. 828, and 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and 
in accordance with 21 CFR part 1312.
    9. Liability. Any activity involving NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA not authorized by, or 
in violation of, the CSA or its implementing regulations is unlawful, 
and could subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures performed ``on the 
record after opportunity for a hearing,'' which are conducted pursuant 
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the 
criteria for scheduling a drug or other substance. Such actions are 
exempt from review by the Office of Management and Budget (OMB) 
pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the 
principles reaffirmed in E.O. 13563.
    This proposed rule does not meet the definition of an E.O. 13771 
regulatory action, and the repeal and cost offset requirements of E.O. 
13771 have not been triggered. OMB has previously determined that 
formal rulemaking actions concerning the scheduling of controlled 
substances, such as this rule, are not significant regulatory actions 
under Section 3(f) of E.O. 12866.

Executive Order 12988, Civil Justice Reform

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This proposed rulemaking does not have federalism implications 
warranting the application of E.O. 13132. The proposed rule does not 
have substantial direct effects on the States, on the

[[Page 42295]]

relationship between the national government and the States, or the 
distribution of power and responsibilities among the various levels of 
government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed 
rule and by approving it certifies that it will not have a significant 
economic impact on a substantial number of small entities. On July 10, 
2018, DEA published an order to temporarily place NM2201, 5F-AB-PINACA, 
4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in schedule I of 
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). DEA estimates that all entities handling or planning to handle 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA have already established and implemented the systems and 
processes required to handle these substances. There are currently 28 
unique registrations authorized to specifically handle NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA, as well as 
a number of registered analytical labs that are authorized to handle 
schedule I controlled substances generally. From a review of entity 
names, DEA estimates these 28 registrations represent 22 entities. Some 
of these entities are likely to be large entities. However, since DEA 
does not have information of registrant size and the majority of DEA 
registrants are small entities or are employed by small entities, DEA 
estimates a maximum of 22 entities are small entities. Therefore, DEA 
conservatively estimates as many as 22 small entities are affected by 
this proposed rule.
    A review of the 28 registrations indicates that all entities that 
currently handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA also handle other schedule I controlled substances, 
and have established and implemented (or maintain) the systems and 
processes required to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, 
MMB-CHMICA, and 5F-CUMYL-P7AICA. Therefore, DEA anticipates that this 
proposed rule will impose minimal or no economic impact on any affected 
entities; and thus, will not have a significant economic impact on any 
of the 22 affected small entities. Therefore, DEA has concluded that 
this proposed rule will not have a significant effect on a substantial 
number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
action would not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100 million or more (adjusted annually 
for inflation) in any 1 year * * *.'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action 
would not impose recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, DEA proposes to amend 21 CFR part 
1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR Part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11,
0
a. Add paragraphs (d)(81) through (85); and
0
b. Remove and reserve paragraphs (h)(31) through (35);
    The additions read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

(81) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate     7221
 (NM2201; CBL2201).............................................
(82) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-    7025
 indazole-3-carboxamide (5F-AB-PINACA).........................
(83) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-        7089
 carboxamide (4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-
 CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78).......................
(84) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-     7044
 methylbutanoate (MMB-CHMICA, AMB-CHMICA)......................
(85) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-     7085
 b]pyridine-3-carboxamide (5F-CUMYL-P7AICA)....................
 

* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-14901 Filed 7-9-20; 10:00 am]
BILLING CODE 4410-09-P